Intravenous Catheter And Insertion Device With Reduced Blood Spatter

ABSTRACT

A catheter insertion device and method for insertion. The catheter insertion device can include a housing, a needle attached to a needle carrier, a catheter including a catheter shaft attached to a catheter hub, and a guidewire. The guidewire can include a coil tip positioned in a lumen of the needle. The method for insertion can include inserting a distal end of the needle and the catheter shaft into a blood vessel of a patient, advancing the coil tip out of the needle lumen and into the blood vessel, advancing the catheter over the guidewire, and withdrawing the guidewire and the needle from the catheter. The coil tip can include a straightened configuration and a coiled configuration. The coil tip can transition from the straightened configuration in the needle lumen to the coiled configuration in the blood vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/192,541, filed Feb. 27, 2014, now U.S. Pat. No. 9,616,201, which is acontinuation of U.S. patent application Ser. No. 13/358,099, filed Jan.25, 2012, now U.S. Pat. No. 8,690,833, which claims the benefit of U.S.Provisional Patent Application No. 61/438,197, filed Jan. 31, 2011, eachof which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices and methods for insertion andplacement of an access catheter into a vein or artery of a patient overa guidewire.

Safe placement of an access catheter into the patient's vein or arteryis particularly difficult in the case of small, tortuous, collapsed,fragile, and/or difficult to locate vessels. The risk of accidentalpunctures and/or contamination by the needle after placement of anintravenous catheter is a particular problem. It is therefore ofinterest to provide devices and methods which protect medical personnelfrom potential exposure to blood from the movement of the retractingguidewire.

Of particular interest to the present invention, access catheters areoften pre-packaged with both a needle and a guidewire where the needleis coaxially received over the guidewire and the catheter is coaxiallyreceived over the needle. The needle extends just beyond the distal tipof the catheter so that the assembly of the needle and catheter can beintroduced into the vein or other vessel. As soon as entry into the veinis detected, typically by observing flashback, the guidewire can beadvanced into the venous lumen, the catheter advanced over theguidewire, and both the needle and guidewire then removed from thecatheter, leaving the catheter available for attachment to sources offluids, drugs or other intravenous materials.

Removal of the needle and guidewire can be problematic as they have atendency to carry patient blood and risk the treating personnel toexposure. This can be a particular problem in the case of guidewireshaving a helical or other shaped tip, such as those described in atleast some of the published U.S. patent applications listed below.

For these reasons, it would be desirable to provide systems and methodsfor use with intravenous and other vascular access catheters to reducethe risk of blood loss and spattering where guidewires and/or needlesare withdrawn from the catheter after placement. It would beparticularly desirable if such methods and devices were compatible withvenous catheters having automatic needle and guidewire retractionmechanisms, as described in the patent publications listed below. Atleast some of these objectives will be met by the invention as describedherein.

2. Background Art

The subject matter of the present invention is related to the followingU.S. patent publications, the disclosures of which are herebyincorporated by reference in their entirety. Each of the variousembodiments of an intravenous catheter insertion device described inthese patent applications can be combined with the intravenous catheterof the present invention to create an intravenous catheter system.

US 2010/0210934, titled, “Intravenous catheter insertion and bloodsample devices and method of use.” US 2010/0094310, titled, “Intravenouscatheter insertion device and method of use.” US 2008/0300574, titled,“Intravenous catheter insertion device and method of use.” Also ofinterest are the following U.S. patents that describe catheters havingsidearm connectors: U.S. Pat. Nos. 5,704,914; 5,154,703; 5,084,023;4,585,440; 4,509,534; and 4,177,809.

BRIEF SUMMARY OF THE INVENTION

The present invention provides venous and other vascular accesscatheters which are adapted to reduce the loss and spattering of bloodupon withdrawal of needles and guidewires used to introduce thecatheters. In particular, the present invention provides a catheterinsertion device comprising an access catheter, a needle, a safetyguidewire, and an actuator mechanism for selectively advancing thesafety guidewire through the needle and selectively withdrawing both theneedle and the safety guidewire from the catheter at desired points inthe catheter insertion protocol. The present invention provides achamber and a septum or other membrane as a “wiping” element on aproximal hub, housing, or other component of the access catheter. Thechamber is preferably disposed at a proximal end of a hub having aninterior chamber spaced apart from a proximal end of the catheter. Aseptum is preferably disposed on a proximal side of the chamber to wiperesidual blood from the guidewire as the guidewire is withdrawn by theactuator. An insertion tool for the needle and/or guidewire is removablyattached to the hub adjacent the septum so that the needle and guidewiremay be advanced through the septum and into the catheter for selectiveadvancement in order to permit introduction of the catheter into anartery or vein in a generally conventional manner. The actuator isfurther adapted to withdraw the needle and guidewire, typically underthe force of a spring or other biasing element which rapidly withdrawsthe needle and catheter into and through the interior of the hub.Usually, the guidewire will be a “safety” guidewire having a helical orother preformed atraumatic shape at its distal end which is assumed whenthe safety guidewire exists from a distal tip of the needle in order toreduce the risk of damaging the vessel as the guidewire is advanced. Asthe guidewire is withdrawn, the safety tip will be straightened as itpasses through the needle lumen and will resume the helical or otherconfiguration within the interior of the hub, thus being able to shedblood which it may have picked up while in the artery or vein into thehub rather than into the surrounding tissue or housing. The guidewirecan then be further withdrawn through the septum in order to remove anyremaining blood before it is drawn back into the actuator for safedisposal. A side port, typically with a side tube, is provided on thehub in order to introduce desired fluids in order to accommodate theseptum or other wiping element which is present on the proximal end ofthe hub.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows an exploded view of an intravenous catheter and insertiondevice according to the present invention.

FIG. 2 shows an assembly drawing of the intravenous catheter andinsertion device in an undeployed state, ready for use.

FIG. 3 shows an intravenous catheter and insertion device in anundeployed state, ready for use.

FIG. 4 shows the intravenous catheter and insertion device of FIG. 3with the guidewire advanced.

FIG. 5 shows the intravenous catheter and insertion device of FIG. 3with the guidewire and needle retracted.

FIG. 6 is an enlarged view of the intravenous catheter of FIG. 3.

FIG. 7 shows an embodiment of the intravenous catheter and insertiondevice with a separate sidearm adapter.

FIG. 8 is an enlarged view of the sidearm adapter of FIG. 7.

FIG. 9 is an enlarged view of another embodiment of an intravenouscatheter according to the present invention.

FIGS. 10 and 11 illustrate another embodiment of a guidewire for usewith the intravenous catheter and insertion device.

FIG. 10 is a proximal end view of the guidewire, and

FIG. 11 is a side view of the guidewire.

FIG. 12 illustrates an embodiment of a steerable guidewire for use withthe intravenous catheter and insertion device.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an exploded view of one embodiment of an intravenouscatheter 100 and insertion device 20 according to the present invention.FIG. 2 shows an assembly drawing of the intravenous catheter 100 andinsertion device 20 in an undeployed state, ready for use. Additionalintravenous catheter insertion devices that can be used in the presentinvention are described in detail in the following patent publications:US 2010/0210934, US 2010/0094310 and US 2008/0300574, which have beenincorporated by reference.

The intravenous catheter insertion device 20 has a housing 21, whichincludes a proximal housing 1 that is adhesively joined or otherwiseconnected to a distal housing 11. In the example shown, the proximalhousing 1 is in the form of an elongated hollow cylinder. The distalhousing 11 is optionally formed in an ergonomic handle shape designed tobe held by the thumb and forefinger of a user. Other shapes are alsopossible. The housing 21 has an elongated slot 22 that extends from theproximal housing 1 to the distal housing 11 approximately parallel witha longitudinal axis of the housing 21. A wire advance slider 3 slides ina longitudinal direction along an exterior of the proximal housing 1 andthe distal housing 11 and has a tongue 23 that extends through the slot22 into the interior of the housing 21. A needle carrier 6 is slidablewithin the interior of the housing 21 and is positioned distal to thetongue 23 of the wire advance slider 3. The distal end of the needlecarrier 6 includes a luer slip fitting 16 or the like. There is a notch24 in the needle carrier 6 just proximal to the luer slip fitting 16. Abutton 25 is located on one side of the distal housing 11, which has atab 26 that is configured to engage the notch 24 in the needle carrier 6when the needle carrier 6 is in its most distal position. A cylindricalguidewire stop 2 is adhesively bonded into the proximal end of theproximal housing 1.

A tubular stainless steel hypodermic needle 7 with a sharpened, beveleddistal end 29 is bonded with adhesive 13 or otherwise attached to thedistal end of the needle carrier 6. Preferably, the needle 7 has one ormore slots 27 cut into the sides of it connecting to the needle lumenfor the passage of blood. A guidewire 9 is bonded with adhesive 14 orotherwise attached to the tongue 23 of the wire advance slider 3. Theguidewire 9 is preferably made of a highly resilient material, such as asuperelastic Nickel-Titanium alloy wire approximately 0.003-0.012 inchesin diameter and most preferably approximately 0.004 inches in diameter.The guidewire 9 may be uniform in diameter or it may be made stepped ortapered in diameter, for example by grinding. For example, a 0.008 inchdiameter wire can be centerless ground to create a 0.004 inch diameterdistal portion with a short tapered transition. Optionally, a proximalportion of the guidewire 9 may be supported with a support tube 8 madefrom stainless steel or Nickel-Titanium alloy hypodermic tubing or amolded or extruded polymer tube. Another option for constructing theguidewire 9 would be to join a short distal portion of a highlyresilient material, such as a superelastic Nickel-Titanium alloy wire,to a larger diameter, solid or tubular proximal portion, for example bywelding, swaging, crimping and/or adhesive bonding. As best seen in FIG.9, the distal end of the guidewire 9 is preformed into a tightly woundspiral 28 with an outer diameter smaller than the internal diameter ofthe target vessel into which it will be inserted. The spiral tip 28 actsas a safety bumper on the guidewire 9 to avoid puncturing or damagingthe inside of target vessels. The coiled guidewire tip 28 isparticularly useful in protecting fragile or delicate veins. Due to theextreme flexibility of the Nickel-Titanium alloy wire, the spiral distalcurve 28 can straighten out when the guidewire 9 is withdrawn into theneedle 7 and completely recover into the spiral configuration withoutplastic deformation when the guidewire 9 is advanced out of the needle7. In the example shown, the distal end of the guidewire 9 has a first,small diameter coil of approximately 0.167 inches in diameter forapproximately 0.75 revolutions and a second, larger diameter coil ofapproximately 0.175 inches in diameter for approximately 1 revolution.The first and second coils are preferably approximately coplanar withone another and preferably approximately coplanar with the straightproximal portion 12 of the guidewire 9 also. Other configurations of theguidewire 9 may include: multi-planar, single coil, full radius on theend, and/or a balled end with a diameter less than the diameter of theneedle.

The guidewire 9 is positioned to move coaxially through the lumen of theneedle 7. Optionally, a flexible tether 4 connects from the tongue 23 ofthe wire advance slider 3 to the proximal end of the needle carrier 6.Optionally, a needle carrier cap 5 may be provided to facilitateadhesively attaching the tether 4 to the proximal end of the needlecarrier 6. The length of the tether 4 prevents the guidewire 9 frombeing withdrawn too far proximally with respect to the needle 7 becausethe small-diameter distal coil 28 would be difficult to reinsert intothe proximal end of the needle 7 if it were to be completely withdrawnfrom the needle lumen. In another option, instead of using a tether, aplastic protrusion or another physical structure, such as a gate, canact as a detent to block the guidewire 9 from withdrawing beyond thedesired point. Optionally, the detent may be configured so that it canbe overrun when a forceful retraction occurs, such as the one that isinitiated by the spring 10, thus allowing complete retraction of theguidewire 9. In another option, the housing 21 may be configured suchthat the guidewire 9 or the structure that is connected to the guidewire9 will hit a positive stop, such as the guidewire stop 2 or the proximalend of the housing 21, before the guidewire 9 gets to a position tooproximal relative to the needle 6.

The proximal housing 1, distal housing 11, wire advance slider 3, button25, needle carrier 6, guidewire stop 2 and needle carrier cap 5 may beformed from any material suited for use in medical applications. Forexample, some or all of these parts may be molded and/or machined from arigid, transparent medical grade plastic, such as acrylic orpolycarbonate.

A compression spring 10 or similar biasing member is positioned betweenthe needle carrier 6 and the distal end of the housing 21 to urge theneedle carrier 6 in a proximal direction. The force of the spring 10 isresisted by the tab 26 of the button 25, which engages the notch 24 inthe needle carrier 6 when the needle carrier 6 is in its most distalposition. It should be noted that in FIG. 1 the spring 10 is shown in acompressed condition as it would be in the assembled intravenouscatheter insertion device 20 in an undeployed condition.

The intravenous catheter 100, which is shown in an enlarged view in FIG.6, has a catheter tube 102 with an inner lumen that fits coaxiallyaround the needle 7 of the insertion device 20. The catheter tube 102 ispreferably extruded of a flexible medical grade polymer having a lowcoefficient of friction, for example PTFE, polypropylene orpolyethylene. Preferably, the intravenous catheter tube 102 has a closefit with the needle 7 and a tapered distal end to minimize any stepbetween the needle 7 and the catheter tube 102 as they are insertedthrough the wall of a vein.

The proximal end of the catheter tube 102 is connected to a proximalfitting 104 that connects to the distal end of a flexible sidearm tube106, which extends laterally from the side of the proximal fitting 104.Preferably, the proximal fitting 104 is molded of a clear polymer sothat blood flashback from the needle 7 can be observed in the proximalfitting 104. A luer fitting 108 or the like is attached to the proximalend of the sidearm tube 106. A fluid flow path is formed from the luerfitting 108 through the sidearm tube 106 to the proximal fitting 104 andthe catheter tube 102. Preferably, the fluid flow path is free ofobstructions, sudden changes of diameter or dead spaces that wouldinterfere with fluid flow or be a nidus for thrombus formation.Optionally, the intravenous catheter 100 may include wings 105, whichfacilitate taping the intravenous catheter 100 to the patient's skinafter insertion. The wings 105 may be rigid or flexible and, optionally,may be molded integrally with the proximal fitting 104.

The hemostasis valve 110 is preferably configured as an elastomericmembrane 112 with a small hole 114 at the center of the elastomericmembrane 112. The hole 114 forms a sliding seal around the needle 7 ofthe insertion device 20. Alternatively, the elastomeric membrane 112 maybe intact and the needle 7 will form a hole 114 as it is insertedthrough the membrane 112. The elastomeric membrane 112 can be made oflatex, silicone, polyurethane or another medical grade elastomer.Optionally, a small amount of medical grade lubricant, such as siliconeoil, may be used to reduce the friction of the needle 7 passing throughthe hemostasis valve 110. Other configurations of hemostasis valvesknown in the industry, such as those having different configurations ofmembranes, holes, slits or duckbill valves, may also be used.Optionally, more than one or a combination of different hemostasisvalves 110 may be used.

Optionally, located proximal to the hemostasis valve 110 is a wipingelement 120. The wiping element 120 is adapted to remove blood from thesurface of the guidewire 9 and needle 7 as they are withdrawn from theintravenous catheter 100. The wiping element 120 may be made of anabsorbent or superabsorbent material to absorb blood from the surface ofthe needle 7 and guidewire 9. Examples of suitable materials include,but are not limited to, cotton wool, gauze, felt, natural or artificialsponge, open-cell foam, etc. Alternatively, the wiping element 120 maybe configured as an elastomeric membrane that acts like a squeegee toremove blood from the surface of the guidewire 9. The elastomericmembrane will preferably be sufficiently elastic to adapt to the largerdiameter of the needle 7 and then to the smaller diameter of theguidewire 9 when the needle 6 has been withdrawn. Preferably, the wipingelement 120 is made with a hole or slit 122 in the center that isaligned with the hole 114 in the hemostasis valve 110. Alternatively,the wiping element 120 may be intact and the needle 7 will form a hole122 as it is inserted through the wiping element 120.

Optionally, there may be a luer fitting 27 or the like on the proximalfitting 104 of the intravenous catheter 100 that fits onto a luer slipfitting 16 on the distal end of the needle carrier 6 with a slightinterference fit to hold the intravenous catheter 100 in place, as shownin FIGS. 1 and 2. Alternative configurations of the device may use aluer lock or other locking mechanism to temporarily attach theintravenous catheter 100 to the insertion device 20. Alternatively, thefriction of the needle 7 passing though the hemostasis valve 110 andwiping element 120 may be sufficient to hold the intravenous catheter100 onto the insertion device 20.

An optional feature of the intravenous catheter 100 in any of theembodiments described herein is a means 142 for selectively blocking oroccluding fluid flow through the flexible sidearm tube 106. This can bein the form of a tubing clamp or stopcock located on the flexiblesidearm tube 106 or on the luer fitting 108, as shown in FIGS. 1 and 2.Alternatively, a separate stopcock can be connected to the luer fitting108 for selectively blocking fluid flow.

FIGS. 3-5 illustrate steps in a method of inserting an intravenouscatheter 100 using an intravenous catheter insertion device 20, such asthose described above in connection with FIGS. 1, 2 and 6. Theintravenous catheter 100 and insertion device 20 are provided as asingle-use, non-reusable device supplied to the physician or othermedical practitioner sterile in a ready-to-use, undeployed condition, asshown in FIG. 3. In another option, the device can be stored with thedistal spiral portion 28 of the guidewire 9 advanced distally from thetip of the needle 7 so that it is not straightened during storage. Inthis case, the operator will fully retract the guidewire 9 into theneedle 7 before use. In use, the operator uses the housing 21 as ahandle to manipulate the intravenous catheter 100 and insertion device20. With the device in the undeployed condition, the needle 7 is used topuncture a vein. When venous blood is observed in the proximal fitting104, the operator knows that the distal tip of the needle 7, togetherwith the distal part of the catheter tubing 102, is in the lumen of thevein. The operator can then advance the slider 3 in the distal directionto extend the guidewire 9 out of the needle 7 into the lumen of thevein, as shown in FIG. 4. The distal portion of the guidewire 9 assumesits spiral configuration 28 to act as a safety bumper to preventaccidental puncture of the far wall of the vein or other damage to thevein and also to enable passage along obstructions such as valves orcurves. With the guidewire 9 thus deployed, the operator can safelycontinue advancing the intravenous catheter 100 until it is inserted farenough into the vein, then the operator pushes the button 25, whichdisengages the tab 26 from the notch 24 in the needle carrier 6. Thespring 10 urges the needle carrier 6 and the slider 3 in the proximaldirection, thus simultaneously withdrawing the needle 7 and theguidewire 9 into the housing 21, leaving only the intravenous catheter100 in the lumen of the vein. FIG. 5 shows the insertion device 20 withthe needle 7 and the guidewire 9 withdrawn into the housing 21.Preferably, the coil 28 on the distal tip of the guidewire 9 is visiblewhen the insertion device 20 is in the deployed position, as shown inFIG. 5. This allows the operator to verify that the guidewire 9 isintact and that only the intravenous catheter 100 has been left in thepatient's vein.

While it is desirable for the insertion device 20 to withdraw the needle7 and the guidewire 9 simultaneously, the actuator mechanism could alsobe modified to withdraw the needle 7 and the guidewire 9 sequentially.For example, the actuator mechanism could withdraw the needle 7 firstand then, after a slight delay, withdraw the guidewire 9. Alternatively,the actuator mechanism could be modified to require two separate motionsof one actuator member or selective movements of two separate actuatormembers to withdraw the needle 7 and the guidewire 9 selectively. Asanother alternative, the spring 10 may be omitted from the actuatormechanism, thus allowing the needle 7 and the guidewire 9 to bewithdrawn manually using the slider 3. Once the intravenous catheter 100has been inserted into the patient's vein, the slider 3 is movedproximally along the slot 22 to withdraw the needle 7 and the guidewire9 into the housing 21.

FIG. 7 shows an embodiment of the intravenous catheter 100 and insertiondevice 20 with a separate sidearm adapter 130. FIG. 8 is an enlargedview of the sidearm adapter 130 of FIG. 7. The structure of theintravenous catheter 100 is similar to that described above inconnection with FIG. 6, except that the proximal fitting 104 has a maleluer connector 132 on its distal end that interlocks with a female luerconnector 134 on the proximal end of the catheter tube 102.

FIG. 9 is an enlarged view of another embodiment of an intravenouscatheter 100 according to the present invention. The proximal fitting104 and the sidearm 106 may be integral to the intravenous catheter 100,as shown in FIG. 9, or they may be part of a separate sidearm adapter,similar to that shown in FIGS. 7 and 8. In this embodiment, the proximalfitting 104 has a first chamber 136 in fluid connection with thecatheter tube 102 and a second chamber 138 separated from the firstchamber 136 by the hemostasis valve 110. Optionally, a wiping element120 for removing blood from the guidewire 9 is located on the proximalside of the second chamber 138. Preferably, the second chamber 138 issized to allow the coiled tip 128 of the guidewire 9 to resume itscoiled configuration after it is withdrawn through the hemostasis valve110. Any dripping or spattering of blood from the guidewire 9 will occurin the second chamber 138. The optional wiping element 120 will help toremove any remaining blood from the guidewire 9 as it is withdrawn fromthe second chamber 138.

FIGS. 10 and 11 illustrate another preferred embodiment of a guidewire 9for use with the intravenous catheter 100 and insertion device 20 of thepresent invention. FIG. 10 is a proximal end view of the guidewire 9,and FIG. 11 is a side view of the guidewire 9. The guidewire 9 ispreferably made of a highly resilient material, such as a superelasticNickel-Titanium alloy wire with a uniform diameter of approximately0.003-0.012 inches and most preferably approximately 0.004 inches. Thedistal end of the guidewire 9 is preformed into a tightly wound spiral28 with an outer diameter smaller than the internal diameter of thetarget vessel into which it will be inserted. Due to the extremeflexibility of the Nickel-Titanium alloy wire, the spiral distal curve28 can straighten out when the guidewire 9 is withdrawn into the needle7 and completely recover into the spiral configuration without plasticdeformation when the guidewire 9 is advanced out of the needle 7. In theexample shown, the spiral distal curve 28 of the guidewire 9 is in theform of a helix with approximately three coils or rotations ofsubstantially uniform diameter. In a particularly preferred embodiment,the helical coils of the spiral distal curve 28 have an outer diameterof approximately 0.052 inches (approximately 1.3 mm). Alternatively, thespiral distal curve 28 may be in the form of a conical helix with coilsthat diminish or increase in diameter. In the example shown, the helicalcoils of the spiral distal curve 28 have a central axis that isperpendicular to and offset from an axis defined by the proximal portion12 of the guidewire 9. In other embodiments, the central axis of thespiral distal curve 28 may be skewed from the axis of the proximalportion 12 of the guidewire 9. Other possible configurations of thespiral distal curve 28 of the guidewire 9 are described in patentpublications US 2010/0210934, US 2010/0094310, and US 2008/0300574,which have been incorporated by reference.

The proximal portion 12 of the guidewire 9 is preferably supported witha support tube 8 made from stainless steel or Nickel-Titanium alloyhypodermic tubing or, alternatively, a molded or extruded tube made of apolymer, such as, but not limited to, FEP, PEEK or HDPE. The supporttube 8 will preferably have an inner diameter sufficient for theproximal portion 12 of the guidewire 9 to be inserted through it, forexample 0.006 inches inner diameter to accommodate a 0.004 inch diameterguidewire 9. The support tube 8 will preferably have an outer diameterof approximately 0.012-0.016 inches and most preferably approximately0.014 inches. Optionally, the support tube 8 may be adhesively bonded orotherwise attached to the proximal portion 12 of the guidewire 9 withthe distal end of the support tube 8 positioned a short distanceproximal to the spiral distal curve 28. The support tube 8 may have atapered distal end 144, which may be formed by a molding process or byapplying a filet of adhesive or other material during assembly.

FIG. 12 illustrates another embodiment of a guidewire 9 for use with theintravenous catheter 100 and insertion device 20 of the presentinvention. The guidewire 9 may be made from a uniform-diameter wire or atapered wire and may optional be supported by a support tube 8 asdescribed above. The spiral distal curve 28 of the guidewire 9 may beany of the configurations described or incorporated herein. There is abend 140 of approximately 30 to 60 degrees in the guidewire 9 a shortdistance, for example 1 to 5 mm, proximal to the spiral distal curve 28.The bend 140 may be located just at the distal end 144 of the supporttube 8 or, optionally, the bend 140 may be located a short distance, forexample 1 to 5 mm, distal to the distal end 144 of the support tube 8.The bend 140 allows the guidewire 9 to be used in a steerable fashion tofacilitate negotiating tortuous and/or branching blood vessels.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousfeatures and embodiments, adaptations and variations can be made to theinvention without departing from the spirit and scope thereof.

What is claimed is:
 1. A method for inserting a catheter into a patient,comprising: providing a catheter insertion device including: a housing;a needle attached to a needle carrier, the needle and the needle carrierdesigned to move relative to the housing; a catheter including acatheter shaft attached to a catheter hub, the catheter shaft positionedcoaxially over the needle; and a guidewire having a coil tip including astraightened configuration and a coiled configuration, the coil tippositioned in a lumen of the needle in the straightened configuration,the guidewire designed to move relative to the housing and the needle;inserting a distal end of the needle and the catheter shaft into a bloodvessel of the patient; advancing the coil tip out of the needle lumen,wherein the coil tip transitions from the straightened configuration tothe coiled configuration in the blood vessel; advancing the cathetershaft over the guidewire; and withdrawing the guidewire and the needlefrom the catheter, wherein the coil tip transitions from the coiledconfiguration to the straightened configuration in the catheter shaft,and from the straightened configuration to the coiled configuration inthe catheter hub.
 2. The method according to claim 1, wherein thewithdrawing comprises releasing a biasing member coupled to the needlecarrier to urge the needle carrier toward a proximal end of the housing.3. The method according to claim 2, wherein a proximal end of theguidewire is simultaneously urged toward the proximal end of the housingalong with the needle carrier.
 4. The method according to claim 2,wherein a proximal end of the guidewire is urged toward the proximal endof the housing after the needle carrier.
 5. The method according toclaim 4, wherein the needle carrier and the proximal end of theguidewire are urged toward the proximal end of the housing via a singleactivation of an actuating member.
 6. The method according to claim 4,wherein the needle carrier and the proximal end of the guidewire areurged toward the proximal end of the housing via two separateactivations of an actuating member.
 7. The method according to claim 1,wherein the withdrawing comprises manually moving the needle carrier anda proximal end of the guidewire toward a proximal end of the housing. 8.The method according to claim 7, wherein the withdrawing comprisessimultaneously moving the needle carrier and the proximal end of theguidewire toward the proximal end of the housing.
 9. The methodaccording to claim 1, wherein the catheter hub includes a septum and awiping element positioned proximal to the septum, further comprisingmoving the coil tip through the septum and the wiping element.
 10. Themethod according to claim 1, further comprising moving an actuatorhandle distally to advance the guidewire in a distal direction andmoving the actuator handle laterally to initiate the withdrawing. 11.The method according to claim 1, wherein the catheter hub includes aproximal chamber separated from a distal chamber by a septum, whereinthe coil tip transitions to the coiled configuration in the distalchamber.
 12. The method according to claim 11, wherein the catheter hubincludes a wiping element proximal to the septum, wherein thewithdrawing comprises moving the coil tip from the distal chamber to theproximal chamber through the septum, and from the proximal chamberthrough the wiping element.
 13. The method according to claim 12,wherein following moving the coil tip through the wiping element, thecoil tip is distal to a distal end of the housing and visible to a user.14. The method according to claim 1, wherein the catheter insertiondevice further comprises an interlocking member in the housing engagedwith a mating interlocking member on the needle carrier, wherein acompression spring is initially in a compressed state and constrained byengagement of the interlocking member with the mating interlockingmember, and wherein an actuator mechanism is actuated to disengage themating interlocking member from the interlocking member, thus releasingthe compression spring to urge the needle carrier in a proximaldirection.